Compositions and methods for body weight loss

ABSTRACT

The present invention relates to herbal compositions and methods for regulating body weight, especially for promoting body weight loss, for maintaining or controlling body weight, reducing blood levels of circulating chemical fuels (e.g., glucose, carbohydrates, fatty acids, and cholesterol), facilitating or promoting metabolism, treating diabetes, treating body weight disorders, and the like.

[0001] The present application claims the benefit of U.S. ProvisionalApplication Serial No. 60/376,526, filed May 1, 2002, which is herebyincorporation by reference in its entirety.

DESCRIPTION OF THE INVENTION

[0002] The present invention relates to herbal compositions and methodsfor regulating body weight, especially for promoting body weight loss,for maintaining or controlling body weight, reducing blood levels ofcirculating chemical fuels (e.g., glucose, carbohydrates, fatty acids,and cholesterol), facilitating or promoting metabolism, treatingdiabetes, treating body weight disorders, and the like.

[0003] Compositions useful for modulating weight loss, include:

[0004] 1. An herbal composition comprising at least two ingredientsselected from rhubarb, green tea, or chitosan, wherein each ingredientsis an amount effective to promote body weight loss, maintain or controlbody weight, reduce blood levels of circulating chemical fuels,facilitate or promote metabolism, treat diabetes or other blood sugardisorders, etc. A composition can comprise, e.g., all three ingredients,or pairs of ingredients, such as rhubarb and green tea, rhubarb andchitosan, and green tea and chitosan

[0005] 2. An herbal composition comprising rhubarb, green tea, and/orsea weed, wherein each is present in an amount effective to promote bodyweight loss, maintain or control body weight, reduce blood levels ofcirculating chemical fuels, facilitate or promote metabolism, treatdiabetes or other blood sugar disorders, etc. A composition cancomprise, e.g., all three ingredients, or pairs of ingredients, such asrhubarb and sea weed and green tea and sea weed.

[0006] 3. An herbal composition comprising rhubarb, green tea, andkonjac, wherein each is present in an amount effective to promote bodyweight loss, maintain or control body weight, reduce blood levels ofcirculating chemical fuels, facilitate or promote metabolism, treatdiabetes or other blood sugar disorders, etc. A composition cancomprise, e.g., all three ingredients, or pairs of ingredients as longas konjac is included, e.g., rhubarb and konjac, or green tea andkonjac.

[0007] 4. Herbal compositions of formula 1, 2, and 3 can furthercomprise one or more additional ingredients selected from: green tea,konjac, sea weed, ginger root, hawthorn fruit, lotus leaf, alisma root,duckmeat herb, wolfberry fruit, jujube fruit, sparganium root, and ricevinegar, wherein each is present in an amount effective to promote bodyweight loss, maintain or control body weight, reduce blood levels ofcirculating chemical fuels, facilitate or promote metabolism, treatdiabetes or other blood sugar disorders, etc.

[0008] 5. An herbal composition comprising rhubarb root, lotus leaf,duckmeat herb, cinnamomi stem, bitter orange, and alisma, wherein eachis present in an amount effective to promote body weight loss, maintainor control body weight, reduce blood levels of circulating chemicalfuels, facilitate or promote metabolism, treat diabetes or other bloodsugar disorders, etc.

[0009] 6. Herbal compositions of formula 5, can further comprise one ormore additional ingredients selected from: hawthorn fruit, red rootedsage, areca catechu fruit, and perilla fruit, wherein each is present inan amount effective to promote body weight loss, maintain or controlbody weight, reduce blood levels of circulating chemical fuels,facilitate or promote metabolism, treat diabetes or other blood sugardisorders, etc. 7. An herbal composition comprising one or more of thefollowing ingredients: green tea, ginseng, konjac and seaweed, whereineach is present in an amount effective to promote body weight loss,maintain or control body weight, reduce blood levels of circulatingchemical fuels, facilitate or promote metabolism, treat diabetes orother blood sugar disorders, etc. The composition can further compriseone or more of any of the other ingredients mentioned herein.

[0010] Various combinations of the ingredients can be used, including,e.g.,

[0011] According to formula 1,

[0012] (1) An herbal composition, comprising green tea from about 25-70%by weight of said composition, rhubarb root from about 25-80% by weightof said composition, and chitosan from about 1-75% by weight of saidcomposition. Any amount of ingredients can be used which are effectiveto achieve the desired purpose. For instance, about 0.5 gram-20 gms,0.5-5 gms, 0.5-3 gms, 2 gms, can be administered one or more times aday, such as three times a day, depending upon the subject's physicalcondition and the potency of the ingredients included.

[0013] (2) An herbal composition comprising: green tea extract, fromabout 40-60%, such as 45%, e.g., 500 mg; rhubarb 5:1 extract, from about40-50%, such as 45%, e.g., 450 mg; and chitosan containing 90%Deacetylation, from about 5-15%, such as 5%, e.g., 50 mg.

[0014] (3) An herbal composition comprising: green tea extract, fromabout 40-60%, such as 50%, e.g., 500 mg; and rhubarb root 5:1 extract,from about 40-50%, such as 50%, e.g., 500 mg.

[0015] (4) An herbal composition comprising: rhubarb root 5:1 extract,from about 2540%, such as 25%, e.g., 500 mg; and chitosan containing 90%Deacetylation, from about 55-75%, such as 75%, e.g., 1500 mg.

[0016] (5) An herbal composition comprising: green tea extract, fromabout 25-35%, such as 25%, e.g., 500 mg; rhubarb root 5:1 extract, fromabout 25-35%, such as 25%, e.g., 500 mg; and chitosan containing 90%Deacetylation from about 34-60%, such as 50%, e.g., 1000 mg.

[0017] (6) An herbal composition comprising green tea extract from about25-70%, rhubarb root 5:1 extract from about 25-50%, hawthorn fruit 5:1extract from about 530%, lotus leaf 5:1 extract from about 4-20%, alismaroot 5:1 extract from about 5-30%, and duckmeat leaf 5:1 extract fromabout 4-20%. An example of such formula is green tea leaf 5:1 extractfrom about 30%, rhubarb root 5:1 extract from about 40%, hawthorn fruit5:1 extract from about 10%, lotus leaf 5:1 extract from about 6%, andalisma root 5:1 extract from about 8%, and duckmeat leaf 5:1 extractfrom about 6%.

[0018] According to formula 2,

[0019] (1) An herbal composition, comprising green tea leaf extractcomprising from about 25-70% by weight of said composition, rhubarb rootfrom about 25-50% by weight of said composition, and sea weed from about5-75% by weight of said composition. Examples include, where the greentea extract is present in about 30%, the rhubarb root 5:1 extract inabout 50%, and sea weed dry powder in 20%; where the green tea extractis present in about 45%, the rhubarb 5:1 extract in about 40% and thesea weed dry powder in 15%. Any effective amount of the composition canbe administered. For instance, about 0.5 gram-20 gms, 0.5-5 gms, 0.5-3gms, 2 gms, can be administered one or more times a day, such as threetimes a day, depending upon the subject's physical condition and thepotency of the ingredients included.

[0020] (2) The composition of (1) can further comprise sparganium fromabout 5-30% and ginseng root from about 3-15%. Examples include, wherethe green tea extract is present in about 35%, the rhubarb root 5:1extract in about 45%, sea weed dry powder in about 10%, sparganium 5:1extract in about 15%, and ginseng root powder in about 3%; where thegreen tea extract is present in about 50%, the rhubarb 5:1 extract inabout 15%, sea weed dry powder in about 20%; sparganium 5:1 extract inabout 10%; and ginseng root powder in about 5%.

[0021] (3) The composition of (1) can further comprise rice vinegar fromabout 30-300 liters per 100 kilograms of said composition. Examplesinclude, where the green tea extract is present in about 30%, rhubarbroot 5:1 extract in about 50%, sea weed dry powder in about 3%, hawthornfruit 5:1 extract in about 10%, wolfberry fruit 5:1 extract in about 6%,and jujube fruit 5:1 extract in about 1%, and 50 liter rice vinegar forevery 20 kilograms of the above composition.

[0022] According to formula 3,

[0023] (1) An herbal composition, comprising green tea leaf extractcomprising from about 25-70% by weight of said composition, rhubarb rootfrom about 25-80% by weight of said composition, and Konjac from about5-75% by weight of said composition. Examples include, where the greentea extract is present in about 30%, the rhubarb root 5:1 extract inabout 40%, and Konjac powder extract containing 90% Glucomannan in 30%;where the green tea extract is present in about 40%, the rhubarb 5:1extract in about 45% and the Konjac powder extract containing 90%Glucomannan in 15%. Any effective amount of the composition can beadministered. For instance, about 0.5 gram-20 gms, 0.5-5 gms, 0.5-3 gms,2 gms, can be administered one or more times a day, such as three timesa day, depending upon the subject's physical condition and the potencyof the ingredients included. (2) The composition of (1) can furthercomprise sea weed from 3-50%. Examples include, where the green teaextract is present in about 30%, the rhubarb root 5:1 extract in about40%, Konjac extract containing 90% glucomannan in about 20%, and seaweed powder in about 10%.

[0024] (3) The composition of (1) can further comprise sparganium fromabout 5-30% and ginseng root from about 3-15%. Examples include, wherethe green tea extract is present in about 25%, the rhubarb root 5:1extract in about 32%, konjac extract containing 90% glucomannan in about20%, sea weed dry powder in about 10%, sparganium 5:1 extract in about10%, and ginseng root powder in about 3%; where the green tea extract ispresent in about 20%, the rhubarb 5:1 extract in about 40%, konjacextract containing 90% glucomannan in about 20%, sea weed dry powder inabout 10%; sparganium 5:1 extract in about 8%; and ginseng root powderin about 2%.

[0025] (4) The composition of (1) can further comprise rice vinegar fromabout 30-300 liters per 100 kilograms of said composition. Examplesinclude, where the green tea extract is present in about 30%, rhubarbroot 5:1 extract in about 40%, konjac extract containing 90% glucomannanin about 20%, sea weed dry powder in about 10%, and 50 liter ricevinegar for every 20 kilograms of the above composition.

[0026] According to formula 4 and 5:

[0027] (1) An herbal composition comprising: Rhubarb Root 5:1 extract,30%; Hawthorn Fruit 5:1 extract, 6%; Lotus Leaf 5:1 extract, 5%; RedRooted Sage (Salvia Root) 5:1 extract, 5%; Alisma Root 5:1 extract, 10%;Areca Catechu Fruit 5:1 extract, 5%; Duckmeat Herb 5:1 extract, 10%;Perilla Fruit 5:1 extract, 9%; Cinnamomi Stem 5:1 extract, 10%; andBitter Orange 5:1 extract, 10%.

[0028] (2) An herbal composition comprising: Rhubarb Root 5:1 extract,30%; Hawthorn Fruit 5:1 extract, 6%, Lotus Leaf 5:1 extract, 5%; RedRooted Sage (Salvia Root) 5:1 extract, 5%; Alisma Root 5:1 extract, 5%;Areca Catechu Fruit 5:1 extract, 5%; Duckmeat Herb leaf 5:1 extract, 5%;Pirelli Fruit 5:1 extract, 9%; Cinnamomi Stem 5:1 extract, 10%; BitterOrange (Citrus aurantium 5:1 extract), 10%; and green tea leaf extract10%.

[0029] According to formula 7:

[0030] (1) An herbal composition comprising: Green tea, from about30-70% by weight of the compostion; Ginseng, from about 1-20% by weightof the composition; Konjac, from about 10-70% by weight of thecomposition; and Seaweed about 10-70% by weight of the composition. Thegreen tea can be present as an extract, e.g., comprising about 25%polyphenol and/or 7% caffeine. The ginseng can be present as a rootpowder or extract. The Konjac and seaweed can be used as a fine powder.

[0031] Any effective species and/or variety of ginseng can be used,e.g., Panax ginseng or Korean ginseng. Any effective species and/orvariety of seaweed can used, especially, sargassum or lainaria japonicaaresch.

[0032] (2) An herbal composition, comprising: about 35% by weight ofgreen tea, about 1% by weight of ginseng, about 14% by weight of Konjac,and 50% by weight of seaweed.

[0033] The amounts of the ingredients, individually or in combination,are effective in promoting weight loss, maintaining or controlling bodyweight, reducing blood levels of circulating chemical fuels (e.g.,glucose, carbohydrates, fatty acids, and cholesterol), facilitating orpromoting metabolism, treating diabetes, treating body weight disorders,etc. An “effective amount” indicates that the mass of ingredient oringredients in the composition is useful to achieve the purpose forwhich it is administered. Amounts are selected based on various factors,including age, health, gender, and weight of a patient or animal to betreated, etc. Useful amounts include, about 0.5 gram-20 gms, 0.5-5 gms,0.5-3 gms, 2 gms, 1 gm per dosage, one or more times a day, such astwice a day, or three times a day, etc., depending upon the subject'sphysical condition and the potency of the ingredients included.

[0034] The ingredients can be combined in “synergistic amounts.” Bythis, it is meant that the amounts of the ingredient present in thecomposition (and in combination with the other ingredients) is moreeffective at achieving the desired purpose (e.g., promoting weight loss)than when administered alone or in another herbal composition. Synergyindicates that the ingredients cooperate with each other to achieve anenhanced or superior result than would be achieved if either wereadministered alone, i.e., the effect is not additive (the sum is greaterthan the sum of the individual parts).

[0035] The present invention relates to methods of modulating bodyweight in a subject, comprising, e.g., administering to a subject inneed thereof a composition comprising an effective amount of anycomposition, ingredient, or ingredients, as mentioned above.

[0036] By the phrase “modulating body weight in a subject,” it is meantthat the mass of a subject is controlled, regulated, changed, altered,modified, etc. A subject can be any individual, human or non-humananimal (e.g., cow, pig, sheep, goat, mice, rats, pets, such as dogs andcats, etc.) in need of weight modulation.

[0037] The compositions are especially useful for promoting weight loss.The phrase “promoting weight loss,” indicates that the compositions andmethods are useful to encourage, elicit, cause, produce, etc., reductionin the mass of a subject's body. The loss in mass can be from a tissue,such as fat and muscle, where stored lipids, proteins, carbohydrates,and/or liquids, such as water, are lost. The invention is not limited byhow much weight loss is promoted of facilitated. For instance, it can be0.25%, 0.5%, 1%, 5%, 7%, 10%, or more of total body weight.

[0038] The invention is not limited by how the reduction in weight lossoccurs. Various mechanisms, acting alone or in combination, produce theweight loss effect. This includes, e.g., promoting metabolism, promotingutilization of chemical fuels (e.g., fats and carbohydrates), reducingblood cholesterol levels, acting as diuretic, promoting utilization ofstored fuels, such as fat from adipose tissue and glycogen,

[0039] To achieve weight modulation, a composition in accordance withthe present invention is administered to a subject. By the term“administered,” it is meant that the composition is delivered to asubject by any means or route which is effective to achieve the desiredresult, including, e.g., oral, parenteral, enteral, intraperitoneal,topical, transdermal (e.g., using any standard patch), ophthalmic,nasally, local, non-oral, such as aerosal, inhalation, subcutaneous,intravenous, intramuscular, buccal, sublingual, rectal, vaginal,intra-arterial, intrathecal.

[0040] Compositions can be administered at any time suitable time. Forexample, compositions can be administered before, after, or togetherwith an activity to be effected, e.g., prior or after a meal, prior toexercise, prior to a sporting event, etc. Times can vary, e.g., about 6hours, 4 hours, 2 hours, 1.5 hours, 1 hour, 30 minutes, 15 min, 10 min,5 min, etc., to the activity which is to be effected. Additionally, thecompositions can be administered concurrently with the activity. Whereweight-loss and/or control is desired, compositions of the invention canbe administered when nutrients from a meal or snack begin to appear inthe blood, i.e., the absorptive state, when ingested nutrients areentering the blood from the gastrointestinal tract. See, e.g., HumanPhysiology, Vander et al., Fifth Edition, 1990, e.g., Chapters 16 and17. The adsorptive state can vary, depending upon the content of thefood, e.g., from about 1 hour to about 4 hours.

[0041] The compositions can be in any effective form, including, oral,pill, capsule, troche, liquid, extract, beverage, food, tea, topical,injectable, etc. They can be administered alone, or in combination withother active or inert agent(s).

[0042] Any effective part of an herb in accordance with the presentinvention can be used, including to seeds, leaves, stems, flowers,roots, berries, bark, or any other plant parts that are useful for thepurposes described. Herbs can be in any form which is effective,including, but not limited to dry powders, grounds, emulsions, extracts,and other conventional compositions. To extract or concentrate theeffective ingredients of an herb, typically the plant part is contactedwith a suitable solvent, such as water, alcohol, methanol, or any othersolvents, or mixed solvents. The choice of the solvent can be maderoutinely, e.g., based on the properties of the active ingredient thatis to be extracted or concentrated by the solvent.

[0043] Herbs can be used as 5:1 extract, e.g., an aqueous extract. Thisindicates that the dry weight of the herb is concentrated five times(5:1) in the extract. Any of the aforementioned formula can be preparedwith a 5:1 extract, and any of the aforementioned values can refer tothe weight of the extract. Green tea (O. ktze.) can be used as anextract containing about 10% caffeine and about 18% epigallocatechin) or5:1 extract prepared from a dry powder. It can also be used as anextract containing about 7% caffeine and about 25% polyphenol.

[0044] Compositions can further comprise inert and carrier ingredients,stabilizers, antioxidants, etc., including, but not limited to, water,salt solutions, alcohols, gum arabic, vegetable oils, benzyl alcohols,gelatin, carbohydrates such as lactose, amylose or starch, magnesiumstearate, talc, silicic acid, viscous paraffin, perfume oil, fatty acidmonoglycerides and diglycerides, pentaerythritol fatty acid esters,hydroxy methylcellulose and the like. Other additives include, e.g.,antioxidants and preservatives, coloring, flavoring and diluting agents,emulsifying and suspending agents, such as acacia, agar, alginic acid,sodium alginate, bentonite, carbomer, carrageenan,carboxymethylcellulose, cellulose, cholesterol, gelatin, hydroxyethylcellulose, hydroxppropyl cellulose, hydroxypropyl methylcellulose,methylcellulose, octoxynol 9, oleyl alcohol, povidone, propylene glycolmonostearate, sodium lauryl sulfate, sorbitan esters, stearyl alcohol,tragacanth, xanthan gum, and derivatives thereof, solvents, andmiscellaneous ingredients such as microcrystalline cellulose, citricacid, dextrin, dextrose, liquid glucose, lactic acid, lactose, magnesiumchloride, potassium metaphosphate, starch, and the like.

EXAMPLE

[0045] A clinical trial was performed using Tea Light, an herbalcomposition comprising, by weight, 35% green tea, 50% seaweed, 14%konjac, and 1% panex ginseng. A double blind, placebo controlled humanclinical trial on the weight loss effect of Tea Light on a total 43obesity patients was conducted. Patients in the Tea Light group took twoTea Light capsules (500 mg/capsule) each time, twice a day (i.e., about2 grams/day), for six weeks. Patients in the control group took twoplacebo capsules (500 mg/capsule) each time, twice a day, for six weeks.Patients were instructed to avoid a diet rich in fat, sugar, and saltfor the period of the treatment.

[0046] At the end of the six week trial, the average weight loss of thepatients in the Tea Light group was about 5.6 kg or 12.3 lb. For theexperimental group, total body weight was from about 84.2±126.5 kgbefore the trial, to 78.6±16 kg after taking Tea Light. For the controlgroup, the average weight loss of the patients in the control grouptaking placebo capsules was about 1.9 kg or 4.2 lb. Total body weightwas about from 83.8±127.6 kg before the trial, to 81.9±29.5 kg aftertaking the placebos. Conclusion: Tea Light was effective for promotingweight loss. The average weight loss was about 0.93 kg or 2.1 lb perweek.

What we claim:
 1. An herbal composition comprising: green tea, ginseng,konjac, and seaweed, wherein each ingredient is present in an amounteffective to promote body weight loss, maintain or control body weight,reduce blood levels of circulating chemical fuels, facilitate or promotemetabolism, or treat diabetes and other blood sugar disorders.
 2. Anherbal composition of claim 1, comprising by weight, 30-70% green tea,120% ginseng, 10-70% konjac, and 10-70% seaweed.
 3. An herbalcomposition of claim 2, comprising by weight, 30-40% green tea, 15%ginseng, 10-20% konjac, and 40-60% seaweed
 4. An herbal composition ofclaim 2, comprising by weight, 35% green tea, 1% ginseng, 14% konjac,and 50% seaweed.
 5. An herbal composition of claim 4, wherein theginseng is panex ginseng.
 6. An herbal composition of claim 2, whereinthe green tea is an extract comprising 25% polyphenol and 7% caffeine.7. An herbal composition of claim 4, wherein the green tea is an extractcomprising 25% polyphenol and 7% caffeine.
 8. An herbal composition ofclaim 1, wherein said amounts are effective to promote body weight loss.9. An herbal composition of claim 1, wherein said amounts aresynergistic.
 10. A method of promoting weight loss, comprisingadministering an effective amount of a composition of claim
 1. 11. Amethod of promoting weight loss, comprising administering an effectiveamount of a composition of claim
 2. 12. A method of promoting weightloss, comprising administering an effective amount of a composition ofclaim
 3. 13. A method of promoting weight loss, comprising administeringan effective amount of a composition of claim
 4. 14. A method ofpromoting weight loss, comprising administering an effective amount of acomposition of claim
 6. 15. A method of promoting weight loss,comprising administering an effective amount of a composition of claim7.
 16. A method of claim 13, wherein 1-3 grams a day of said compositionis administered.